To compare the effectiveness of needling with 5-fluorouracil 5% cream versus topical 88% phenol application in the treatment of vitiligo

Phase 2

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2023/07/055803
• Lead Sponsor: Vinayaka Missions Medical College

Brief Summary

After applying inclusion and exclusion criteria .History and written consent from the patient is taken. Topical anesthesia will be applied over lesions .

For Group A patients A layer of 5-FU cream 5% will be  applied over the lesions. Microneedling will be done with DermaPen using the lowest speed with needle penetration depth. After cleaning with betadine, equal quantities of 5-FU cream 5% and fusidic acid cream 2% were applied The procedure will be  repeated every 2 weeks for  6 sessions and followed up at monthly intervals for next 3 months 

For Group B Patients Topical 88% phenol will  applied once gently with uniform smooth strokes to cover the entire lesion till an ivory white uniform frosting appeared. Prophylactic antibiotic cream will be applied twice in a day till the lesions healed Patients followed up at every 2 weeks for 3 months and at monthly intervals for next 3 month

Clinical improvement and side effects will be assessed after each session

.T   The study will be concluded with the comparison of clinical improvement of both group A and group B study population.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Last Update Posted: 2023-07-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with clinical diagnosis of stable vitiligo Patients who are willing to participate in the study.

Exclusion Criteria

Patients with unstable vitiligo Patients allergic to 5-fluorouracil 5% cream and 88% phenol Patients with predisposition to keloids Patients and lactating mothers Patients not willing for procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the clinical response by repigmentation to microneedling with 5-fluorouracil 5% cream and topical 88% phenol application in the treatment of vitiligo	At the end of 3 months, and 6 months

Secondary Outcome Measures

Name	Time	Method
Treatment side effects	Every 4 weeks for 3 months

Trial Locations

Locations (1)

VINAYAKA MISSIONS MEDICAL COLLEGE; 🇮🇳 Karaikal, PONDICHERRY, India

VINAYAKA MISSIONS MEDICAL COLLEGE

🇮🇳Karaikal, PONDICHERRY, India

DR V SIVASUBRAMANIAN

Principal investigator

9884835199

hoddvdvmmckkl@gmail.com